Current health systems built to evaluate and pay for traditional drugs are going to struggle with gene and other unusual therapies – but manufacturers can take steps before launch to define how manufacturers assess and value these new products.

A recent study of DTC advertising appearing in the Journal of General Internal Medicine concluded that few broadcast ads are compliant with FDA’s guidelines. The reality, though, might not be so cut and dried.

As more innovative – yet even more expensive – therapies enter the U.S. market, brand marketers will have to find equally new and innovative ways to prove the value of their medicines to payers and patients, especially as insurance plans continue to put more of the cost burden on patients.

On Oct. 28, 2016, my mother, Joan Biamonte, died of complications from metastatic carcinoma of the lung. Despite having her original tumor characterized and going through a regimen of chemotherapy allegedly tailored to her tumor type, her cancer proliferated and spread into her liver and brain.

U.S. doctors and hospitals throw out almost $3 billion (roughly 2.7 billion euros) in unused cancer drugs each year because the medicines come in supersized single-use packages and excess medicine must be discarded for safety reasons, a recent paper suggests. Researchers focused on 20 expensive medicines that are given by injection or intravenous drip and […]

A cancer drug originally discovered in Britain has finally been endorsed for treating advanced prostate cancer before chemotherapy on the country’s state health service in a change of heart by the cost agency NICE.

New York state Attorney General Eric Schneiderman’s office has asked 16 health insurers for documentation on patients who have been denied coverage of drugs used to cure hepatitis C, a person familiar with the matter told Reuters on Wednesday. Schneiderman’s office also requested details on procedures followed by the companies to authorize the drugs used […]

A new leukemia drug viewed by industry experts as a future blockbuster has been rejected by Britain’s healthcare cost-effectiveness agency NICE, which said it could not be confident the medicine represented an effective use of resources. Imbruvica has a list price of 55,954.50 pounds ($78,000) a year, although it is being offered at an undisclosed […]

AstraZeneca has sold rights to a non-core drug to a unit of Kyowa Hakko Kirin for an upfront payment of $70 million, a day after getting $500 million for two ageing heart medicines. The British-based drugmaker has been divesting peripheral products to help pay the bills as it invests in new medicines, while taking […]

By Joseph Pierro, chief medical officer of Biomedical Systems. In many clinical trials, clinical imaging plays an important role in the drug development process. Whether the trial involves drugs, biologics, or devices, imaging may be used to measure the efficacy and safety of the investigational product. An independent assessment based on the centralized […]

China plans to consolidate its huge and fragmented drug market and will support a greater role for traditional Chinese medicines (TCM), the central government said in a statement on Sunday following a meeting of the State Council. China will also strengthen safety controls and traceability of domestic drugs, the statement said, part of an […]